Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

NCT07456787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.

Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.

Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.

These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.

To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.

To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.

Conditions

  • Total Knee Arthroplasty\(TKA\)
  • Osteoartrosi

Interventions

DEVICE

Cryopressotherapy

Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes

DEVICE

Ice pack

Comparison between ice pack and cryopressotherapy

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Principal Investigators

  • Laura Mangiavini · University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2025-10-13
Completion
2028-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456787 on ClinicalTrials.gov